Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485741
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2020-07-21
Brief Title:
Strados System at Center of Excellence
Sponsor:
Strados Labs Inc
Organization:
Strados Labs Inc
Study Overview
Official Title:
Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Listening to breath sounds with the stethoscopeauscultation is used by pulmonary physicians in conjunction with pulmonary function signs and symptoms oxygen saturation and diagnostic testing to admit follow and discharge patients from hospital Of these only auscultation routinely ceases upon discharge from Hospital Healthcare utilization statistics have shown that for more than a decade readmission after discharge for an exacerbation of COPD or severe asthma or chronic heart failure remains a major problem The Strados System has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring The primary purpose of this study is to assess the clinical utility of the Strados System in enabling periodic recording and reviewing of breath sounds in patients with chronic respiratory diseases either in the ICU or in less continuously monitored settings including after inpatient discharge
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None